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# EIP Pharma Fast Track for Dementia Drug
- URL: https://www.fdaweb.com/eip-pharma-fast-track-for-dementia-drug/
- Published: 2019-11-07T12:00:00.000Z
- Updated: 2026-09-14T15:52:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145443

FDA has granted EIP Pharma a Fast Track designation for neflamapimod as a treatment for dementia with Lewy bodies (DLB). The company is planning a Phase 2 proof-of-concept study (AscenD-LB) of neflamapimod in mild-to-moderate DLB. The primary objective is to determine whether neflamapimod can improve synaptic dysfunction in patients with DLB, as assessed by a neuropsychological test battery evaluating attention, executive function and visuospatial deficits. Data from the study are expected in the second half of 2020\. The AscenD-LB study is registered at clinicaltrials.gov as study NCT04001517 ([https://clinicaltrials.gov/ct2/show/NCT04001517](https://c212.net/c/link/?t=0&l=en&o=2635293-1&h=3257770010&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04001517&a=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04001517&ref=fdaweb.com)).

Neflamapimod is described by EIP Pharma as a brain-penetrant, oral small molecule that inhibits the intra-cellular enzyme p38 MAP kinase alpha (p38a). P38a, which is expressed in neurons under conditions of stress and disease, plays a major role in inflammation-induced synaptic toxicity, leading to impairment of synaptic function, it says.

DLB is a serious disease affecting 20% of the dementia population, with an estimated 1.4 million affected individuals in the U.S., according to the company. It is characterized by progressive dementia and fluctuating cognition (deficits in memory and attention), sleep disturbances, visual hallucination and Parkinsonism (tremor and gait disturbances).